Quality Engineer II

SMC Ltd.•Devens, MA

9d•$64,600 - $110,000•Onsite

About The Position

The Quality Engineer II is responsible for all areas of Quality Engineering and working directly with the engineering, tooling and manufacturing functions making sure adequate systems, inspection methods and tools are used throughout the plants for molding and assembling products. Understanding customer requirements and implementing action plans, purchasing equipment or tools necessary to perform tasks. Ensure proper controls, operator instructions and quality tools used to verify customer’s products at all phases within our process.

Requirements

Bachelor of Science Degree or Associate's degree with 5 years of experience
5-7 years’ of experience as a Quality Engineering within drug and medical device industries
Must have experience with 21 CFR Part 820 Quality System Regulation
Must have experience with 21 CFR Part 4 Combination Product Regulation
Must have experience with ISO 13485
Must be able to read and understand 2D detailed part/article drawings
Must understand the use all Quality related inspection equipment
Must have excellent problem solving and mistake proofing skills
Must have computer skills and familiarity with Word and Excel programs
Must have knowledge of SPC
Effective interpersonal and problem solving skills
Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization
Excellent written, verbal, and presentation skills

Nice To Haves

Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
Working knowledge of the ISO 13485 & ISO 9001standards.
FAIR inspection, DHR & control of documents.
Good technical, analytical and trouble shooting skills.
Equipment experience with: VMS, CMM, Vernier caliper, micrometer, height gauge, etc.
Experience within medical device manufacturing within a contract manufacturing setting.

Responsibilities

To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.
To maintain device history records (DHR) & product release checklist for each lot.
To conduct inspections at in-process, in-coming and complete the final inspections.
To prepare technical documents like DMR & DHR.
To maintain microbial record in ISO class-7 & class-8 as per procedure.
Creating master documents to track calibration & latest version of documents and records.
To prepare control plan, FMEA & FAIR documents.
To prepare 8D and supplier CAPA reports.
Monitoring calibration activities.
Perform metrology activities & drawing reviews.
Coordinates investigation, root cause analysis & corrective action.
Product & process validation requirements & implementation.
IQ, OQ, PQ validation/qualification